Quality Manual Iso 9001-2008
Quality manual ISO 9001-2008
TABLE OF CONTENTS
Quality Iso 9001:2008-Quality Manual Overview and Purpose
Quality Management System
Measurement- Analysis and Improvement
Quality System Forms and Templates
Using the documents of the Quality Key Business Area
The Key Business Area named Quality ISO9001:2008 and its sub-sections are designed to reflect the order and format of the requirements of the ISO9001:2008 Quality Management System Standard (QMS).
Whilst these documents will enable your organisation to complete much of the documentation for accreditation to the standard, there is more that must be done.
What to do now
It is necessary to review and edit these documents to ensure that, as a whole, they represent your internal systems accurately. There may be many other documents that you will need to evidence that your Quality Management System is integrated and evidenced in every area of your organisation.
It is strongly recommended that an experienced Quality Consultant be appointed to guide the documentation and implementation process.
Each document in this suite begins with purpose statement, followed where possible by a suggested procedure for compliance with the particular element of the standard. Where the text is shown in red, this indicates that it is indicative of the text that is required or the text requires expansion.
All red text should be reviewed, adjusted and converted to normal text before completion.
All Quality Management system requirements have been detailed individually. Your quality consultant or auditor may suggest an amalgamation of procedures based on the nature of your organisation.
Attached supporting files
ISO 9001:2008 Gap Analysis
This document will assist you to evaluate your organisation against each of the ISO 9001:2008 requirements.
ISO 9001 Compliance
This document will become useful as you further expand or simplify the template documents of the Quality Key Business Area and develop additional material that may be located elsewhere in your database of quality documentation.
The organisation chart is used to demonstrate in graphic form, the structure or relationship of each role in the organisation. You should identify and clearly indicate a management representative as being the Quality Manager.
Depending upon the size and nature of the organisation, this manager may or may not have other managerial responsibilities.
You may wish to insert a screen shot of your organisation chart, as shown in the TKO main screen, but be careful not to insert this until it has been fully developed.
Locating the organisation chart/tree in TKO
Insert the organisational tree here, to do so
Click the hyperlink button
Select “Topics in database” from radio group on hyperlink dialog
Select “key roles and job decriptions” from the tree
Click the “Insert Selected items” then “Selected and children” from the drop down
Then to insert into your document click “Apply linked list items”
Key Roles/ Job descriptions
- Our Business
- Managing Director
- Marketing Manager
- Marketing Assistant
- New role
- Sales Manager
- Sales Person
- Finance Manager
- Payroll Clerk
- Human Resources Manager
- Safety Manager
- First Aid Officer
- Administration Manager
- Office Cleaner
- Quality Manager
- Environmental Manager
- Team member
- Marketing Manager
- Managing Director
1.1.0 Quality Management System – Requirements. Scope – General
The international standard, ISO9001-2008, specifies the requirements for the Quality Management System (QMS) where the organisation needs to demonstrate that it is able to meet its customer’s requirements together with any statutory and regulatory obligations.
The QMS is designed to develop customer satisfaction through its application, the processes for continual improvement and assurance of conformance with the requirements of the customer and any applicable statutory or regulatory requirements.
This Quality Manual provides specific details of the policies and procedures used by [enter-your-company-name-here] to meet the requirements of the international standard ISO9001-2008
Our QMS demonstrates [enter-your-company-name-here]’s ability and commitment to consistently provide products and/or services that meet our customer’s requirements and applicable statutory, regulatory or legal requirements.
In addition, our QMS aims to enhance the level of customer satisfaction through the effective application of the policies and procedures, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory, regulatory or legal requirements.
Whenever our QMS refers to “product”, this applies only to;
- product intended for, or required by, a customer; or
- any intended output resulting from the product realisation processes
1.2.0 Scope – Application
The requirements of the international standard ISO9001-2008 are generic in order that they may be applied to all organisations, irrespective of their nature, size or product provided.
Consequently, where the requirements of the standard are not applicable to the organisation and cannot therefore be applied, they may be considered for exclusion.
Claims of conformity with the international standard ISO9001-2008, may only be made when all exclusions are limited to the requirements of Clause 7 of the standard.
In addition, the exclusions shall not affect the organisation’s ability or responsibility to provide products or services that comply with the customer’s requirements and any statutory, legal or regulatory requirements.
[enter-your-company-name-here] has no permissible exclusions as they apply to the organisation or its products under the requirements of the international standard ISO9001-2008.
[enter-your-company-name-here], due to the nature of the organisation and its products, has excluded section 7.3 Design and Development from the applicable requirements of the ISO9001 2008 standard.
This exclusion does not affect the organisation’s ability or responsibility to provide products or services that comply with the customer’s requirements and any statutory, legal or regulatory requirements.
2.0.0 Normative reference
To establish the current status of documents in the Quality Management System, the international standard ISO9001-2008 states;
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
3.0.0 Terms and definitions
For the purposes of interpretation, the terms and definitions given in ISO 9000 apply to the international standard ISO9001-2008. Wherever the term “product” is used, it may also mean “service”.
Terms and definitions
Where the term “organisation” is used in this quality manual, it refers to [enter-your-company-name-here]
“Supplier” and “Vendor” are synonymous and refer to the external source used to acquire purchased products and/or services by [enter-your-company-name-here].
Throughout the text of this Quality Manual wherever the term “product” occurs, it may also mean “service”.
4.1.0 Documentation Requirements – General
The organisation is required to establish, document, implement and maintain a quality management system and to continually improve its effectiveness in accordance with the requirements of the International Standard ISO9001-2008.
In order to do this, the organisation must;
- determine the processes that must be included in the quality management system and how these should be applied throughout the organisation. These processes include those for management, provision of resources, product realisation, measurement, analysis and improvement.
- determine the relationship and interaction of these processes with one another,
- determine methods and criteria necessary to effectively operate and control the processes,
- provide the necessary resources and information to support the operation and monitoring of these processes,
- monitor, measure where applicable, and then analyse these processes,
- implement actions that are necessary to achieve the planned results and provide continual improvement of these processes. The management of the processes must be carried out in a manner that complies with the requirements of the International Standard ISO9001-2008.
- When the organisation decides to outsource any process that may affect the product’s conformity to requirements, it must ensure that it maintains control over these processes. The type and extent of control necessary will be defined within the quality management system but must include compliance with all customer, statutory and regulatory requirements. In addition, the controls should cover the potential impact of the outsourced process on the organisation’s capability to provide product that conforms to requirements and the degree to which the control for the process is shared. The level of control that may be achieved through the application of Clause 7.4 (Purchasing) should also be considered.
- [enter-your-company-name-here] has established, documented, implemented and maintains a Quality Management System in accordance with the requirements of the International Standard ISO9001-2008. The organisation is pro-active in the management of the system; monitoring and continually improving it to ensure that it is compliant with the standard and meets the needs of its customers.
- [enter-your-company-name-here] considered the entire organisation to determine the process that were required for its Quality Management System and the application of these processes.
- In developing the relationship and order of the processes, the organisation considered the interaction of these at all levels.
- [enter-your-company-name-here] has determined relevant criteria and methodology to ensure that both the operation and control of these processes is effective.
- [enter-your-company-name-here]’s top management are committed to ensuring the provision of resources and information necessary to support the operation and monitoring of the processes associated with its Quality Management System.
- As part of its policy of continual improvement, [enter-your-company-name-here] fully supports the monitoring, measurement (where applicable) and analysis of the processes associated with its Quality Management System.
- Any actions necessary to achieve the planned results and continual improvement of the organisation’s processes will be implemented and supported by top management.
- [enter-your-company-name-here] will ensure that the development and management of its processes shall be in accordance with the requirements of the international standard ISO9001-2008.
The organisation does not outsource any process that affects product conformity to the requirements of its Quality Management System.
The organisation will outsource certain processes that may affect product conformity to the requirements of its Quality Management System. These processes and the control measures employed are detailed within the Quality Management System.
4.2.1 System Documented
The Quality Management System documentation shall include;
- documented statements of quality policy and quality objectives,
- a quality manual,
- documented procedures and records required by the International Standard. A documented procedure is one that has been established, documented, implemented and is maintained.
- A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document, and
- documents, including records, determined by the organisation to be necessary to ensure the effective planning, operation and control of its processes. The extent of the documentation can differ from one organisation to another due to;
- the size of organisation and type of activities,
- the complexity of processes and their interactions, and
- the competence of personnel.
This documentation can be in any form or type of medium.
[enter-your-company-name-here] has documented all systems and procedures that are required to comply with the requirements of the International Standard ISO9001-2008 and to provide documentation for the organisation to operate effectively.
The documentation includes statements of quality policy and quality objectives, a quality manual, documented procedures and records. In some cases, a single document will address the requirements for one or more procedures.
A requirement for a documented procedure will, in some cases, be covered by more than one document.
The documentation may be in any form or type of medium such as written, electronic, diagrammatic or visual depending upon the application.
4.2.2 Quality Manual
The organisation shall establish and maintain a quality manual that includes;
- the scope of the Quality Management System
- details of and the justification for any exclusions, that the organisation is claiming, to the Quality Management System
- details of the interaction or relationship between the processes of the Quality Management System.
[enter-your-company-name-here] has established a Quality Manual that is central to its Quality Management System (QMS) and identifies the manner in which its system references the International Standard ISO9001-2008.
The operating procedures, referenced in the Quality Manual, are written using specific terms and language that is commonly used in our business.
The Quality Manual details the scope of the QMS. The table of contents for this manual provides a control register for the scope of the system. Any exclusions to the International Standard are detailed in the Quality Manual (see 1.2)
Where necessary, references are included in the Quality Manual to show the interaction of the processes contained in the QMS.
All documentation is controlled and no part of any document may be used or reproduced in any manner whatsoever without direct authorisation of the (Managing Director).
4.2.3 Control of Documents
[enter-your-company-name-here] has established procedures for the control of its documentation in compliance with the international standard ISO9001-2008.
These procedures ensure that the documentation is current and authorised by controlling;
- the approval of document for use, prior to issue
- the review process, updating and the re-approval of the document
- the method of identification of changes and the revision status
- arrangements for documents to be made available at the point of use
- arrangements to ensure that all documents are legible, identifiable and usable
- methods by which all documents of external origin, that are determined by the organisation to be necessary for the planning and operation of the Quality Management System, are identified as such and that the distribution of them is controlled
- methods by which obsolete documents are identified and their unintended use prevented, together with the application of identification marks where these are retained for any purpose.
(This document states generically the details of how a business may respond to this requirement. Your specific internal response must be completed below in the body of this procedure. Your use of TKO software may impact the nature of the response)
Document control is a vital aspect of assuring the image and integrity of [enter-your-company-name-here]’s business.
This procedure controls internal and external documents to ensure that:
- Personnel receive procedures and work instructions that are current and approved.
- Clients and the general public receive current business information.
- Specifications are current.
- Current documents are available wherever they are required for the effective functioning of work processes.
- Out of date or superseded documents are removed so they cannot be used.
- Superseded or obsolete documents that are retained, are identified as such.
- New or replacement documents are recorded when changed and issued.
- New or changed procedures identify improvements and processes that add value, wherever possible.
Internal documents are procedures, forms, drawings and instructional and advisory material of a permanent nature, designed and written by or for the business. Internal documents are not records.
All internal documents are identified on the form “Master List : Internal Documents List”. (or are identified in the company TKO database)
For each group of documents on the Master List, kept as hard copy:
- (Place current hard copies where)
- (Fill out and place master list where)
When changing an existing document, the extent of the change is identified and, if minor, the changes are made without printing hard copies.
The changed documents are proof read and checked.
If the change is major or if a new document is being created, a copy is printed. The document is reviewed to determine the impact of the new or changed document on any existing procedures. If procedural changes have occurred or are necessary as a result, these are reviewed by who e.g. MD.
When who has reviewed and approved the changes, the Master copy is printed and filed, new copies are printed and distributed, the old master document is marked superseded and retained for historical purposes where All old copies are located and destroyed and the changes are communicated to all staff.
External documents may include manuals for equipment, brochures, standards, statutory regulations, and codes of practice etc. These items may be considered as the business’s technical library.
An External Documents Register is maintained to track the location, use and currency of all external documents.
Copies of Operations Manuals, procedures or work instructions may be issued to interested parties on request. Whether they are issued as controlled or uncontrolled, is recorded on the Controlled Documents Register.
Uncontrolled copies are marked “UNCONTROLLED COPY: NOT SUBJECT TO UPDATE” on the front cover in red ink, prior to issue.
Controlled copies are marked “CONTROLLED COPY” on the front cover in red ink, prior to issue.
4.2.4 Control of Records
To document the methods that the organisation uses for the control of records, ensuring that they are both legible and identifiable. To document the methods and procedures for the storage, protection, retrieval and retention time and the disposition of all records.
(This document states generically, the details of how a business may respond to this requirement. Your specific internal response must be completed below in the body of this procedure. Your use of TKO software may impact the nature of the response)
- This procedure establishes the controls that identify, maintain and store in good condition, records that provide objective evidence of management and quality control in all areas of our operations.
- A filing system that allows for easy storage and retrieval has been established for all records, and is controlled within our office.
- Our filing systems, unless otherwise specified, are identified, have sections labelled, with individual files neatly kept in alphabetical order.
- Records, whether hard copy or electronic, are kept in a clean, dry and secure location by the custodian to prevent deterioration or loss.
- All leave records for the previous 12 months are archived in archive boxes that are labelled with the contents and a destroy date and stored where The current financial year’s records are then transferred into the 12 months prior file. New files, as appropriate, are set up for the commencement of the new financial year and the 12 months previous records are stored in archive boxes where
- All other files are stored until the retention period is expired, at which time they are removed for safe disposal.
- Retention periods are as set out in legislation, with most items for seven years retention period, however some items are permanently retained for prudence sake.
Such items include:
- Audit reports and financial statements
- Charts of account
- Contracts, mortgages, notes and leases that are unexpired
- Some correspondence (legal and other important matters)
- Deeds, mortgages, bills of sales
- Depreciation schedules
- Year-end financial statements
- General ledgers, year end trial balances
- Property records, including blueprints and plans
- Tax returns and worksheets
5.1.0 Management Commitment
To evidence that top management is committed to the development, implementation and continual improvement of its Quality Management System (QMS).
Top management is responsible for communicating the importance of meeting customer, legal, statutory and regulatory requirements. In addition, top management shall demonstrate its commitment and support for the establishment of a quality policy and quality objectives.
Top management shall conduct regular management reviews and ensure the availability of resources for the operation of the QMS.
[enter-your-company-name-here] asserts that its Quality Management System (QMS) provides evidence of top management’s commitment to the development, implementation and improvement of the QMS.
The procedures in this Manual specifically respond to our commitment at all levels of our organisation including top management to:
- effective communication at all levels of the organisation, especially with respect to the importance of meeting our client’s requirements together with all legal, statutory and regulatory requirements.
- the establishment of the quality policy that includes the organisation’s commitment to quality, continuous improvement and client satisfaction. The quality policy statement is a public document and is endorsed by (who)
- ensuring that quality objectives are established and met through review processes that are documented and recorded.
- the regular management review of the system and its outcomes
- ensuring that the necessary resources are available to manage the system.
(Expansion with details is required here)
5.2.0 Customer Focus
To evidence that the organisation and top management identify and are focussed on customer requirements with the aim of enhancing customer satisfaction.
[enter-your-company-name-here] is entirely customer focussed and devoted to fully understanding the needs and requirements of our clients and ensuring that our products and or services are responsive to these needs and requirements.
This focus is identified in procedures within our company manual.
(Expansion required – Customer service department, salespeople allocated to individual clients or client groups, customer survey, industry trends. Website design, customer feed-back. Reference to 7.2.1 & 8.2.1)
- Understanding the client’s explicit requirements is fundamental to the satisfactory outcome of the project. Extreme care and attention is paid to the process of determining the scope of the work before the commencement of the project (7.2.1)
- A senior (who) is assigned to the client and maintains close contact throughout the duration of the project. Regular meetings are held with the client to ensure that their requirements are being met and any changes or additions are fully understood by all parties concerned.
- Clients are surveyed on a regular basis to ensure that the levels of service are satisfactory and appropriate. Client feedback is sought and encouraged to ensure that the Quality Management System is maintained and relevant (8.2.1).
- [enter-your-company-name-here] maintains an up-to-date web site that provides information on the company’s services together with information for contacting the company.
5.3.0 Quality Policy
To evidence that top management has developed and implemented a quality policy that is appropriate for the organisation and that it includes a commitment to compliance with the requirements of the standard and the continual improvement to the effectiveness of the Quality Management System.
In addition, top management shall ensure that the quality policy provides a framework for the establishment and review of quality objectives, the policy is communicated and understood throughout the organisation and that it is regularly reviewed for continued relevance.
[enter-your-company-name-here] has developed a policy that identifies our commitment to quality and continuous improvement. This policy provides the framework for the maintenance of our objectives in quality and communicates our approach to quality.
[enter-your-company-name-here] provides a quality (insert here a description of your business for example, real estate business).
Our activities include:
- (List of the main and typical activities of your business)
Our Quality Management System provides a framework for addressing;
- the availability of information and resources necessary to support our operations
- the requirement for understanding the needs of our industry and our clients
- the design and development of services to meet market requirements
- the selection and training of staff and contractors to maintain high standards of quality
- the maintenance of continuous quality inspection and testing practices
- regulatory compliance
- the monitoring our client’s level of satisfaction after completion of work
- the need to ensure that, not only our immediate clients but also, other stakeholders benefit from the quality of our work
- the setting and reviewing of measurable business objectives
- the commitment to continuous improvement and suitability of our management system.
This statement is issued to indicate our attitude towards our relationship with our clients and our standards of service. The full support of our employees, suppliers and contractors is sought in actively pursuing this quest for quality.
5.4.1 Quality Objectives
This procedure identifies that we have established Quality Objectives in Key Business Areas of the organisation. These objectives are consistent with our quality policy, have been established by top management and address our management priorities, commercial intent, legal, regulatory and contractual obligations.
We have processes for evaluating these objectives, meeting the needs of interested parties and mitigating risk.
[enter-your-company-name-here] has written objectives for sustaining and improving the business in the areas of:
- Purchasing and procurement
- Sources of business
- Client management
- review our actual performance against these objectives on a regular basis.
- modify and update our written objectives, to continually improve our performance against these objectives.
- have set in place strategic and business planning together with operations planning in order to;
- predict the outcomes for the quarter, updated monthly
- conduct effective, annual business planning
- carry out strategic planning with projected outcomes for 3 to 5 years.
- Our operational plans and financial performance are reviewed monthly and reported to a monthly management meeting.
5.4.2 QMS Planning
To evidence that top management is fully supportive and involved in the planning processes for the Quality Management System (QMS) and quality objectives, as required by 4.1 of the QMS requirements.
When changes to the QMS are planned and implemented, top management will ensure that the integrity of the QMS is maintained.
- [enter-your-company-name-here] conducts a Quality Management System (QMS) review meeting, every six (6) months, to discuss and review the performance of the quality system and to review the Corrective Action Required (CAR) log and trends.
- This meeting is attended by top management and representatives from all parts of the organisation and is designed to consider the performance of the management system as a whole.
- Other management meetings and activities focus on the performance and effectiveness of specific areas of the QMS.
- Staff meetings are held (how often) to discuss CAR’s, unreported CAR’s, ideas, suggestions, equipment issues, suppliers, and OH&S issues.
- Meeting minutes are recorded and the resultant action lists are promptly addressed and signed off when closed.
- Whenever the review process determines that changes are necessary to the QMS, top management will ensure and confirm that the integrity of the QMS and all related documentation is maintained when the changes are implemented.
5.5.1 Responsibility and Authority
To demonstrate that top management has defined and communicates the responsibilities and authorities for staff throughout the organisation.
In accordance with our Quality Management System, individual responsibilities and authorities are communicated to all members of our organisation.
This is carried out as follows:
- Job descriptions are provided to all employees upon commencement of their employment with our organisation
- To do lists are provided to all employees upon commencement of their employment with our organisation
- A individual Systems Manual, detailing all documented procedures and work instructions that are included in the employee’s job description is made available to all employees upon commencement of their employment.
- An Organisation Chart, that shows the relationship of all positions within the organisation, is available to all employees upon commencement of their employment.
- An Induction Manual is provided to all employees upon commencement of their employment.
5.5.2 Management Representative
To identify the appointment of a top management representative, with the title of Quality Manager, who is responsible for establishment, implementation, maintenance, reporting and promotion of the Quality Management System.
We have selected and appointed a Quality Manager from senior management who has a defined role to control the establishment, implementation and maintenance of processes required for the Quality Management System (QMS).
The Quality Manager is responsible for:
- The maintenance of all required records
- Informing management of required changes and developments that may be necessary
- Controlling all documents and data
- Scheduling and maintaining a program for internal auditing of the QMS
- Closing out CAR forms and maintaining the CAR log
The Quality Manager is responsible for the promotion of awareness of customer requirements throughout the organisation and shall conduct regular reviews to ensure that all customer quality objectives are met.
When necessary, the Quality Manager will liaise with external parties, such as sub-contract suppliers, on matters relating to the QMS.
5.5.3 Internal Communication
To identify the methods by which the results and determinations of the Quality Management System review meetings are communicated to every member of the organisation.
[enter-your-company-name-here] holds regular meetings to ensure that the Quality Management System (QMS) is effective, and to discuss any areas for improvement. The meetings are chaired by the Quality Manager and attended by representatives from top management and all other areas of the organisation.
The minutes from these meetings, together with any announcements of new processes or changes, are distributed to all members of the organisation by one or more of the following methods;
- Verbally, in person
- Notice boards
- The office diary
- Message book
- White board
Whenever necessary, meetings or training sessions will be arranged to explain or demonstrate any changes or additions to the QMS. Where appropriate, external parties such as sub-contract suppliers will be involved in the meetings or training sessions.
All QMS and related documentation, forms, drawings, check lists, work instructions, signs, that will be affected by any change or addition is immediately withdrawn from use and replaced with the amended version.
All superseded or redundant material is destroyed or marked superseded and archived for reference purposes.
5.6.1 Management Review – General
To demonstrate that [enter-your-company-name-here]’s top management conducts regular reviews of the Quality Management System (QMS) in order to ensure its continuing suitability, adequacy and effectiveness.
The reviews include the assessment of opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives.
Quality Management System (QMS) review meetings are held every (how often) to ensure that the QMS is effective, is adequate, meets customer quality requirements and to discuss areas for improvement.
The meeting is chaired by the Quality Manager and the following areas are represented by top management;
- Sales & Marketing
- Human Resources
Representatives from other staff levels and areas are represented as appropriate.
The Agenda for the Review Meeting will address the following;
- Assessment of the effectiveness of the QMS in achieving the quality policy and quality objectives;
- Assessment of the QMS with respect to its continuing suitability and effectiveness in satisfying the requirements of the international standard, ISO9001-2008;
- Assessment of likely future requirements to ensure that the QMS will remain suitable and effective;
- Review of the evidence from internal audits, corrective actions, project reviews, customer feedback and quality improvement activities.
Minutes of all meetings are recorded and stored in accordance with the requirements of the standard, clause 4.2.4.
Other management meetings and other activities such as internal audits, consider the effectiveness of specific areas of the Quality Management System.
5.6.2 Review Input
To show the details of input to the management review process 5.6.1 – Management Review – General
The Agenda for the Management Review meeting will respond to the following issues:
- Results from internal audits
- Results from external audits
- Supplier, customer and client feedback
- Industry feedback
- Production and efficiency data
- Non-conformance trends
- Corrective and preventive actions
- Improvements to specific systems such as software, inventory, training, reporting, etc.
- Appropriateness of policy statements
- Any changes in work practices etc. that may affect the Quality Management System.
- Any recommendations for improvements to the Quality Management System.
Minutes are prepared by the Quality Manager, detailing any action necessary and distributed in accordance with 5.5.3 – Internal Communication
5.6.3 Review Output
To show the details of outputs of the management reviews.
The outcomes from the Management Review meetings may include:
- Improvements to procedures, forms and work instructions
- Improved Customer and Client service or value adding
- Improved resource planning and management
- Improved communication systems
6.1.0 Provision of Resources
Identifies that a number of procedures in this manual are devoted to determining and providing resources required to implement, maintain and improve the effectiveness of the Quality Management System and enhance customer satisfaction.
The following documents identify resources that [enter-your-company-name-here] has provided for implementation, maintenance and improvements to the Quality Management System and for enhancing customer satisfaction through meeting customer requirements within the organisation.
- 6.2.1 Human Resources – General
- 6.2.2 Competence, awareness and training
- 6.3 Infrastructure
- 6.4 Work Environment
6.2.1 Human Resources – General
Identifies the existence of system to ensure that [enter-your-company-name-here] has appropriately qualified and experienced staff.
[enter-your-company-name-here] has developed a skills matrix that identifies the necessary education, skills, training, experience and qualifications for all key operations in the organisation. Each position has a position description that is clear and easy to read. The position description clearly identifies the core competencies required for that position.
Training has been identified as integral to ensuring the competency of our people. The processes for this are dealt with in 6.2.2 Competence, awareness and training
6.2.2 Competence, awareness and training
Identifies processes for determining employee competency and training requirements, the provision of same together with communications strategies to assist employees to identify how they contribute to the achievement of our quality objectives.
All employees receive induction into the Quality Management System (QMS) requirements. Immediately upon commencement of duties, employees participate in appropriate training, accept responsibility for the job, ensure quality at their workstations without the need for close supervision or continual inspection of their output and comply with all relevant procedures and work instructions.
Part of this training is to ensure that staff are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.
When additional work loads require part time or casual staff, management will ensure that they comply with the above requirements.
Key objectives in relation to human resources for [enter-your-company-name-here] include:
- Identifying an employee from the best available people
- Providing staff with appropriate training
- Providing staff with opportunities for advancement
- Ensuring that both [enter-your-company-name-here] and its staff benefit during the period of employment
- Providing for replacement staff and staff level planning.
Our staff selection programme involves the design of appropriate job advertisements, that are approved and placed in newspapers etc., provision of application forms and position descriptions, interviews and selection and rejection processes. Recruiting agencies are used when appropriate; a detailed brief and job description is provided to the agency before any work proceeds.
New employees take part in a formal induction program, are supplied with a letter of employment, have their details entered into employee records, have employee files created, and have skills gaps and training requirements identified. Reference is made to the skills matrix that has been established for each position.
In line with [enter-your-company-name-here]’s commitment to continuous improvement, on-going training is programmed, including refresher courses for technology, training in new equipment and processes and the use of new forms.
Ongoing training, not only includes in-house training, but also external training courses when appropriate and available. Attendance of internal training and competency gained is recorded in the training register and attendance qualifications and certificates of attainment are recorded on the employee record.
Regular assessments are carried out to determine the effectiveness of training and the need for any additional training.
To address the provision and maintenance of infrastructure that is necessary to achieve conformity of product requirements.
[enter-your-company-name-here] identifies and provides the necessary infrastructure to support their Quality Management System, this includes;
- Buildings, work areas;
- Lighting, ventilation, climate control;
- Plant and equipment;
- Communication hardware;
- Computer hardware and software;
- Transport and courier services;
- Furnishings; and
- A safe and appropriate working environment for visitors.
6.4.0 Work Environment
To detail the work environment areas that, the organisation has identified, are to be managed to ensure conformity of product requirements.
[enter-your-company-name-here] provides a work environment that conforms to regulations, industry guide lines and contractual requirements.
It provides a positive environment to enhance the performance of all staff. Management ensures that adequate facilities are provided for staff and visitors, with regard to:
- Access, including lifts and ramps,
- Adequate work space,
- Transport requirements,
- Currency of hardware and software,
- Kitchen facilities,
- Toilet and bathroom facilities,
- Safety and security,
- Regulatory compliance,
- First aid and first aid equipment.
With regard to our business processes, we ensure that the following facilities are provided so that product conformity is achieved.
(list here all requirements necessary to the production or services of your business, including any special requirements for climate control, humidity, noise, sterility, dust control, protection from the elements etc.)
7.1.0 Planning of Product Realization
This relates to the planning of the realisation process in order to ensure that all processes ranging from, understanding the customer requirements to providing the product or service, are identified and properly planned.
This includes; (depending on the type of business)
- Identification of the product or service supplied to the customer
- Identifying the quality objectives and requirements
- Identification of any need to establish processes, documents or specific resources for the product or service
- Identifying any required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance
- Identifying any records required to provide evidence that the realisation processes and resulting product or service meets the requirements of the Quality Management System.
- Planning the provision of these product or services, such as the sales or order cycles
- Designing or development of the services
- Procurement of raw materials and other resources
- Producing or providing the product or service
- Installation and support of the product or service
Note (a) A document specifying the processes of the Quality Management System (including the product realisation processes) and the resources to be applied to a specific product, project or contract, can be referred to as a Quality Plan.
Note (b) The organisation may also apply the requirements given in 7.3 to the development of product realisation processes.
Sample flow chart
In relation to this procedure, the following sections should be referenced as appropriate:
- 7.1 Planning of Product Realization
- 7.2.1 Determination of Requirements Related to the Product
- 7.2.2 Review of requirements related to the product
- 7.2.3 Customer communication
- 7.3.1 Design and development planning
- 7.3.2 Design and development inputs
- 7.3.3 Design and development outputs
- 7.3.4 Design and development review
- 7.3.5 Design and development verification
- 7.3.6 Design and development validation
- 7.3.7 Control of design and development changes
- 7.4.1 Purchasing process
- 7.4.2 Purchasing information
- 7.4.3 Verification of purchased product
- 7.5.1 Control of Product and Service Provision
- 7.5.2 Validation of processes for production and service provision
- 7.5.3 Identification and traceability
- 7.5.4 Customer Property
- 7.5.5 Preservation of product
- 7.6 Control of Measuring and Monitoring Devices
7.2.1 Determination of Requirements Related to the Product
To determine that customer requirements, including the requirements for delivery and post-delivery activities are understood and recorded.
Any requirements, not stated but are necessary for the specified or intended use, statutory, legal or regulatory requirements and any others considered necessary shall be determined and noted where appropriate.
NOTE Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal
In determining the requirements relating to a product or service, [enter-your-company-name-here] will;
- identify all potentially suitable tenders and opportunities to quote;
- take care to understand the customer’s requirements;
- ensure that it provides competitive pricing;
- conducts a detailed review of specifications and contracts;
- avoid extra work that cannot be invoiced;and
- ensure regulatory compliance with specifications and contracts.
In preparing quotations and estimates, [enter-your-company-name-here] will;
- make reference to the applicable standards;
- supply product information and technical information and manuals as appropriate;
- make reference to client supplied specifications and previous job files.
- give consideration to special conditions or problems that exist the time of tendering or quoting.
In quoting or tendering [enter-your-company-name-here] will maintain awareness of compliance requirements for areas such as:
- environmental management
- licences, permits and special requirements
In addition, when reviewing specifications, tenders, contracts and the scope of work, [enter-your-company-name-here] will consider the following:
- whether current safety and environmental procedures cover the safety and other considerations in the scope of work.
- whether any new processes or equipment that are required will require assessment and control.
- what costs or resources are required.
- whether there are any legal implications.
- whether it is capable of evaluating the safety and environmental impact and the controls required.
[enter-your-company-name-here] is careful to ensure that it;
- understands which regulations apply to its operations;
- complies appropriately to those regulations;and
- understand its exposure to risk and eliminates or reduces risk to acceptable levels.
[enter-your-company-name-here]’s compliance with regulatory and statutory codes may include, but is not limited to:
- corporate compliance
- Directors’ responsibilities
- privacy legislation
Areas of risk may include, but are not limited to:
- insurance, such as professional indemnity, public liability and material risks;
- security of premises;
- cash security;
- service guarantees;
- public relations, damage control;
- computer data, disaster recovery and data security;
- other areas when identified as applicable.
When a compliance issue, or a risk or threat to the business is identified, [enter-your-company-name-here] will:
- clarify the full extent of the risk;
- inform the top management;
- conduct risk assessments;
- prepare procedures which comply with regulations and render the risk acceptable;
- train staff on the procedure;and
- add a procedure to the relevant section of the operations manual.
[enter-your-company-name-here] regularly and, on a formal basis, actively seeks client feedback, HOW eg regular mail out or customer survey etc…
7.2.2 Review of requirements related to the product
[enter-your-company-name-here] has established procedures to review the requirements related to product or service prior to supply.
These procedures ensure that product or service and customer requirements are defined, contract or order requirements differing from those previously expressed are resolved and the organisation has the ability to meet the defined requirements.
[enter-your-company-name-here] receives requests for the supply of products or services by;
- Verbal communication
- On receipt of an order or request for supply, a suitably qualified person shall determine that all requirements are defined and that the specifications, pricing, terms etc. for the product or service to be supplied, meet the requirements exactly.
- These checks are documented and recorded in the relevant order file.
- Where a quotation has not been issued and a formal review is impractical for each order, such as in the case of Internet orders, the review process shall be limited to comparison with catalogues or advertising material.
- Any variance between the contract or order requirements received with those previously expressed are identified and resolved prior to further processing of the contract or order. These checks are documented and recorded in the relevant order file.
- Checks on stocks, production capacity, resources and other factors affecting supply, shall be made prior to the acceptance of the contract or order. These checks are documented and recorded in the relevant order file.
- Where the request for supply is not supported by a physical document, such as the case with telephone or verbal orders, the contract or order shall be acknowledged in writing before acceptance is recorded. This acknowledgment shall include all relevant details such as specifications, pricing, terms etc. and may be transmitted by Email, letter or facsimile.
- Whenever a change to a product or service requirement is received, supply or production shall be halted immediately and confirmation of this shall be sent to all persons involved in the process. A suitably qualified person shall review the changes and determine the scope of the changes and any necessary action with respect to specifications, pricing, supply times etc.
- When all outstanding issues are resolved, confirmation of the changes and acceptance, together with any notification of specifications, pricing, supply times etc., shall be sent to the customer and any other relevant persons.
- Whenever product requirements are changed, a suitably qualified person shall ensure that relevant documents are amended and that all relevant personnel are made aware of the changed requirements.
7.2.3 Customer communication
To determine effective arrangements for communicating with customers in relation to product information, enquiries, contracts or orders, customer feedback and complaints.
(This document lists some generic responses. Your specific internal response should be framed around these or detailed accordingly)
[enter-your-company-name-here] has established and implemented procedures for communicating with customers as follows;
Product information requests;
A suitably qualified person shall assemble the relevant information and transmit this by means of;
- Pro-forma letter or brochure by post or fax
Enquiries, contracts or order handling, including amendments;
All communications with respect to these matters shall be in accordance the procedure detailed in 7.2.2 – Review of requirements related to the product
Customer feedback, including customer complaints
Feedback from the customer, including customer complaints, may be received by;
- Verbal communication
Except in minor instances, all feedback shall be acknowledged in writing within 24 hours. A minor instance may include a problem where there is no lasting effects such as a one off late delivery.
Any response to the customer shall include the timing for resolution.
If the complaint is as the result of a Quality System failure or warrants a detailed investigation, then a Corrective Action Request (CAR) shall be raised and the matter handled in accordance with the procedure 8.5.2 – Corrective Action.
Feedback from the customer should be included in any documentation associated with the CAR.
7.3.1 Design and development planning
Unless the organisation has claimed an exemption to this clause, it is required to plan and control the design and development of product.
During the design and development planning, the organisation shall determine;
- the stages of design and development
- the necessary and appropriate review, verification and validation processes for each stage
- the responsibilities and authorities for design and development and the manner in which the organisation manages the relationships between the internal and external parties involved to achieve clear communications and assignment of authority.
All documentation associated with the planning function shall be constantly updated throughout the design and development stages.
[enter-your-company-name-here] does not contribute to concept or finished design of products; this element is therefore excluded from the Quality Management System.
[enter-your-company-name-here] intends to control design and design management for the purposes of;
- preparing design and construction estimates and tenders in response to written requests or invitations to tender and,
- designing new products and developing them for the market.
- Re-engineering existing products.
[enter-your-company-name-here] shall be responsible for design management. An appointed Design Project Manager will control the design project.
Design management may include, but is not limited to:
- Establishing the stages of design and development
- Developing a program that defines inputs, outputs and roles, both internal and external
- Defining the role of the Design Consultant
- Creating a project file
- Coordinating information, meetings and project team members
- Advising on conceptual design, suitability for construction and practical issues
- Review of drawings
- Review of the design with respect to the client or market brief
- Review of any prototypes
- Review, approval and sign-off of critical work or stages
- With respect to drawing and specification control;
- Ensure that all drawings and specifications are current, are on site and in Job File
- Hand over new drawings and instructions to site personnel and suppliers
- Remove obsolete documents from the Job File and site locations
- Sign, date and mark old documents “superseded”
- Record names of drawing recipients on the Daily Report.
Where appropriate, a specifically selected, out-sourced design consultant shall be commissioned to carry out, and to be responsible for, design, compliance and finished drawings.
The selection process is based on the consultant having appropriate qualifications, experience with the product to be designed, and appropriate levels of engineering resources.
7.3.2 Design and development inputs
This procedure asserts that, during the design and development phase, the inputs to the design are reviewed in order to assure that they are in conformance with the requirements for the end design. The review process is documented in accordance with the procedure 4.2.4 – Control of records
During and following the design and development phase, [enter-your-company-name-here] conducts assessments to ensure that the inputs will ensure that the final product or service will comply with;
- the customer’s specifications with respect to function and performance
- legal, regulatory, statutory and other requirements
- proprietary design information from previous, similar projects
- quality and reliability inspection and testing requirements
- previous performance ratings for similar projects
- specifications from suppliers and sub-contractors
- other known requirements for the final design in order to be fit for the intended use, where this is known.
The methodology and terms of reference for these assessments are reviewed before, during and after the design and development phase to ensure that they are complete, unambiguous and do not conflict with one another.
Each review is fully documented in the form of a report, citing the methodology and terms of reference used and any supporting data that was used in the review process, such as material specifications, test reports, etc. The documentation is stored in accordance with the procedure 4.2.4 – Control of records
7.3.3 Design and development outputs
This procedure asserts that, during the design and development phase, the outputs shall be in a form that is capable of verification against the design and development inputs. 7.3.2 Design and development inputs.
The design and development outputs shall;
- correlate with the input requirements that were set for the design and development phase.
- be in a form that provides appropriate and sufficient information for the purposes of purchasing, production, service provision and preservation of the product.
- contain or make reference to any product acceptance, relevant industry standards or testing criteria.
- detail any characteristics of the product that are deemed essential for its safe operation or use.
- Technical, construction or performance specifications and associated drawings
- Supplier specifications.
7.3.4 Design and development review
To demonstrate the procedure for review of the design and development process in order to verify that the results will meet requirements and to identify any potential or actual problems and propose necessary actions.
- The regular review process shall be carried out by top management. The timing and frequency of the reviews shall be determined at the start of the project and varied as necessary.
- Participants in the review process shall include representatives of all functions that are associated with the design and development phase/s that is under review.
- Each review is fully documented in the form of a report, citing the methodology and terms of reference used and any supporting data that was used in the review process, such as material specifications, test data, etc.
- The report shall include details of any potential or actual problems that were identified proposed corrective action and the timing for this.
- The documentation is stored in accordance with the procedure 4.2.4 – Control of records
7.3.5 Design and development verification
To identify the procedure used to verify that the design and development outputs have met the design and development input requirements.
- Reviews to verify that the design and development outputs have met the design and development input requirements are carried out by top management.
- The timing and frequency of the reviews may be determined by the Quality Manager or person in charge of the design project, at the start of the project or when necessary.
- Participants in the review process shall include top management, representatives from Sales, Finance, Operations and all functions that are associated with the design and development project.
- Each review is fully documented in the form of a report, citing the methodology and terms of reference used and any supporting data that was used in the review process, such as material specifications, test data, etc. The report may include details of any potential or actual problems that were identified proposed corrective action and the timing for this. The documentation is stored in accordance with the procedure 4.2.4 – Control of records
7.3.6 Design and development validation
To identify the procedure used to validate that the design and development outputs have met or are capable of meeting the customer’s requirements.
- At the completion of the design and development phase, the outputs are reviewed to validate that they have met the design and development input requirements and the product meets the requirements of the customer.
- Wherever practical, this process is carried out prior to the delivery or implementation of the product.
- Participants in the review process shall include top management, representatives from the customer, Sales, Finance, Operations and all relevant functions that were associated with the design and development project.
- Each review is fully documented in the form of a report, citing the methodology and terms of reference used and any supporting data that was used in the review process, such as product specifications, test data, etc. The documentation is stored in accordance with the procedure 4.2.4 – Control of records
7.3.7 Control of design and development changes
To identify the procedure used to control the change process for design and development.
Any changes to the design of a product may be identified and proposed by:
- The Customer
- The Design Consultants engaged in the design and development process
- Representatives of any external parties who have jurisdiction over the design
- Proposed changes are reviewed, verified and validated, as appropriate, and approved before implementation. Participants in the review, verification and validation processes shall include top management, representatives of the customer, all relevant functions associated with design and development and representatives of Sales, Finance and Operations as appropriate.
- Final approval for the design change shall be given after all activities associated with this procedure, including changes to drawings, production processes etc., are completed.
- Any review of proposed changes to design shall include careful evaluation of the effect of these changes on constituent parts and product that may be already delivered.
- The review is fully documented in the form of a report, citing the reasons for the change and any actual or potential effects that the change will cause to constituent parts and product that may be already delivered.
- The report shall contain details of the methodology used, and the results obtained, during the verification and validation processes.
- The documentation shall be stored in accordance with the procedure 4.2.4 – Control of records
7.4.1 Purchasing process
To ensure that purchased product conforms to the requirements of the organisation, particularly where the supplied product is integrated into customer products and services.
All purchases, except for cases where the purchased product has no effect upon the subsequent product realisation or service delivery, shall be made from a supplier listed on the Preferred Supplier Listing and are subject to the following procedure.
[enter-your-company-name-here] selects suitable suppliers that comply with its standards and requirements and who supply product and services at competitive prices.
Materials purchased may include:
- Raw materials for production
- Communication supplies
- Office supplies
- Safety supplies
- Routine consumables
Services engaged may include:
- Electrical contractors
- Design consultants
- Transport services
- IT contractors
- Maintenance contractors
[enter-your-company-name-here] assesses all suppliers, whether they are suppliers of materials or services, and maintains a list of all suppliers on a Preferred Suppliers Listing register.
All suppliers are assessed and rated for performance and suitability every (how long) or more frequently
Suppliers are assessed against the following criteria;
- Geographical locality
- Timeliness and punctuality
- Previous performance as a supplier
- Availability of goods and services
- Range and type products and services
- Business references
All new suppliers are rated as category (Cat) B until the first review
Preferred suppliers are rated as category (Cat) A
Suppliers who have not performed satisfactorily since the last review and, or, have been subject to action under the Corrective Action procedure shall be rated as category B until the next review.
Suppliers who fail to perform satisfactorily for two or more review periods may be removed from the list of suppliers
The records and results of the evaluations shall be stored in accordance with the procedure 4.2.4 – Control of records
7.4.2 Purchasing information
To demonstrate the procedure for purchasing product, especially where the product has an effect upon the subsequent product realisation.
Before commencement of the purchasing process, a suitably qualified person shall verify that the specified purchase is adequate and that all specifications and other information conforms with the requirements for product realisation.
[enter-your-company-name-here] conducts purchases using official purchase orders that include:
- a purchase order number
- a product number where appropriate
- supplier identification
- a description of the product or service type
- the quantity or size
- the price (if known), including any existing negotiated and agreed rates
- reference to standards, (industry and safety specifications), quality, tolerances
- the required delivery time and place
- and special conditions (including provision of certification, or pre- delivery inspection, etc.)
- the signature of an authorised person.
[enter-your-company-name-here] has established authority levels for purchasing:
(detail here the limits and authorisation for routine purchasing for various staff and predefined limits of authority in dollar terms)
Sub-contractors are required to complete and sign a subcontractor agreement and are similarly assessed on compliance, qualification, competency and safety conditions.
As appropriate, [enter-your-company-name-here] may request the right to inspect products and services at the supplier’s premises at agreed or specified stages.
Whenever possible and necessary, customers may also be afforded the right to verify, at [enter-your-company-name-here]’s supplier’s premises, that the product to be supplied conforms to the customer’s specified requirements.
7.4.3 Verification of purchased product
To detail the procedures for inspection and verification of purchased product to ensure that it meets the specified purchase requirements.
[enter-your-company-name-here] verifies that all purchased product, where that product has an effect upon the subsequent product realisation, complies with the specified purchase requirements.
In most cases and where practical, the verification process consists of a visual inspection for condition, product type and quantity. Where this is determined to be satisfactory, the purchase order shall be annotated as follows; “Acceptance subject to visual inspection”.
In other cases, the product shall be subjected to testing and measurement etc. Where this is determined to be necessary, the purchase order shall be annotated as follows; “Acceptance subject to receipt verification”.
All results of these tests and verification methods shall be recorded in the appropriate manner and the records stored in accordance with the procedure 4.2.4 – Control of records.
When product is received, the delivery docket details are recorded in the Goods Inward register, and it is placed in a quarantine area until it is inspected and verified. Inspection and testing shall be carried out without delay as subsequent claims against the supplier may be subject to a defined claims period.
The product is verified for supply conformity as follows;
- The product is checked against the delivery docket and copy of the purchase order
- If the purchase order indicates “Acceptance subject to receipt verification”, the product is inspected for damage and the supplied quantity is verified against the delivery docket. If this inspection is satisfactory, the delivery docket is marked with a pen or permanent marker, “Visual Inspection O.K.” together with the receivers initials. The product is then placed in the quarantine area with the delivery docket attached, pending further inspection and verification; otherwise
- If the purchase order indicates “Acceptance subject to visual inspection”, and the product complies with that specified on the delivery docket and purchase order, the delivery docket is marked with a pen or permanent marker, “O.K.” together with the receivers initials.
- The “Goods Checked” column of the Goods Inward register is initialled to signify that all necessary checks have been completed.
- the delivery docket and copy of the purchase order are then stapled together and forwarded to the Accounts department.
- the product is placed in store and made available.
Acceptance subject to receipt verification
When product is designated “Acceptance subject to receipt verification”, further inspection and testing shall be carried out without delay. Subsequent claims against the supplier may be subject to a defined claims period.
When testing and verification is complete, and the product is considered satisfactory, the steps 3 to 6 above shall be followed.
Product fails verification
If the product fails to pass the inspection or testing and verification process, then it is returned to the quarantine area and clearly marked, “HOLD”. If necessary, a CAR is raised and a copy attached to the product.
A report is forwarded to the purchasing department, together with a copy of any test results and a copy of the CAR if applicable.
The product shall remain quarantined and shall not be released until authorised by the Quality Manager or his designate.
Off-site inspection, testing and verification
Where [enter-your-company-name-here] or its customer intends to perform inspection, testing and verification at the supplier’s premises, [enter-your-company-name-here] shall state the intended verification arrangements and method of product release on the purchase order.
7.5.1 Control of Product and Service Provision
To ensure that the planning and activities of production and service provision are conducted under controlled conditions.
[enter-your-company-name-here] has established controlled conditions for the planning and realisation of product and service provision.
Controlled conditions include;
- the availability of information and documentation that describes the specifications of the product or service. This information is available in the form of manuals, MSDS’s, specification sheets, links to the Internet web site, audio visual media etc.
- a range of work instructions that identify every element of our production processes and, or service delivery has been established and implemented. Master copies of these documents are maintained and controlled as detailed in the process documented in this Manual under 4.2.3 Control of Documents.
- the use of plant and equipment that has been designed, selected and calibrated to produce product or services under controlled conditions.
- where necessary or specified in the work instructions, monitoring and measuring equipment such as vernier gauges, micrometers, rules, pressure gauges, multimeters, oscilloscopes, levels, etc are provide for in-process checking.
- where monitoring and measuring devices are used for checking and verification, these are inspected, checked and calibrated on a regular basis that is documented and audited.
- product inspection at prescribed points in the realisation of the product and before final release.
- processes for packing and delivery activities are traceable, verifiable and documented.
- processes for installation, on-site testing, commissioning and warranty activities are traceable, verifiable and documented.
All documentation is stored in accordance with the procedure 4.2.4 – Control of records
7.5.2 Validation of processes for production and service provision
Where processes cannot be fully verified immediately, using normal inspection and testing processes, the actions taken to validate these processes are identified in this procedure.
This may be the case where testing would destroy the product such as destructive tests to confirm the strength of a weld. Or where the final strength of a product such as concrete, which may take 28 days to cure, cannot be determined immediately after the pouring process.
- Where processes cannot be fully verified by our normal inspection and testing processes, [enter-your-company-name-here] identifies these in its quality plan and develops and implements procedures to ensure that the product specifications are achieved.
- [enter-your-company-name-here]’s top management undertake to ensure that, wherever such processes are carried out, providers or personnel, responsible for such processes and for ensuring the conformance of outcomes, are adequately qualified and that their skills are periodically reviewed through adequate sampling.
- Any equipment, used for the validation process, is approved by top management after it has been verified as fit for purpose and is subject to periodic calibration and review.
- The methods and procedures used for validation of the process or service will be dependant upon the type. Expansion is required here to detail specific instances where this will apply.
- The validation process is documented in the form of a report, citing the methodology used and any supporting data that was obtained, such as temperature, humidity, process times, machine settings etc.
- The documentation is stored in accordance with the procedure 4.2.4 – Control of records
- Whenever the sampling results show excessive variation, the process is re-validated.
7.5.3 Identification and traceability
This procedure details how [enter-your-company-name-here] identifies product at all stages of development and realisation.
- Where appropriate, [enter-your-company-name-here] identifies product at all stages of realisation. Identification is achieved by means of…………
- Where appropriate, the status of monitoring and measurement is identified at all stages of product realisation. Identification is achieved by………
- This data may be required by the customer.
- Where appropriate, [enter-your-company-name-here] maintains records during product realisation to provide traceability. Expansion required. Option: configuration management is a means by which identification and traceability are maintained.
- All records are stored in accordance with the procedure 4.2.4 – Control of records
7.5.4 Customer Property
To identify, verify and protect customer property.
- [enter-your-company-name-here] ensures that all property left in its custody, including intellectual property, is handled with care and respect.
- Customers may entrust their property for repair, as samples, for integration in a product or for other purposes. [enter-your-company-name-here] has procedures for recording the full description and identification marks of the property including details of ownership and all other details as necessary in the Customer Property Register.
- Customer property shall be clearly identified as such, together with appropriate identification of the owner, and stored “where”.
- In the event of lost property, a description of the property and the circumstances in which it was located will be made in the Lost Property Register and the customer notified immediately..
- Unidentified, lost property will be tagged as such and stored “where”.
- Damaged or unsuitable customer property shall be recorded in the Customer Property Register and the customer notified immediately.
7.5.5 Preservation of product
This procedure identifies how [enter-your-company-name-here] preserves the product and its constituent parts throughout realisation to final supply in order to ensure conformance to requirements.
[enter-your-company-name-here]’s procedures covering product realisation, ensure that it and the constituent parts are identified at all stages to maintain conformity to requirements. Procedures cover the handling, packaging, storage and protection of the product and the constituent parts ensure preservation during product realisation and delivery.
Any latent defects are identified and rectified prior to acceptance by the customer.
7.6.0 Control of Measuring and Monitoring Devices
- provide the measuring and monitoring equipment that is necessary to provide evidence of product or service conformity.
- provide processes that ensure that monitoring and measurement are carried out and that this is consistent with the requirements of the customer.
- provide processes for the checking and calibration of measuring and monitoring equipment to ensure conformity, accuracy and traceability.
- [enter-your-company-name-here] ensures that appropriate measuring and monitoring equipment is employed to provide evidence that the product conforms to requirements at various stages of realisation.
- [enter-your-company-name-here] has procedures that ensure that measurement and monitoring of the product is carried out at all stages of production, that the results are consistent with requirements and that the results are recorded.
- All measuring and monitoring equipment is regularly calibrated or verified against measurement standards traceable to international or national measurement standards and recorded in Calibration Registers; where no such standards exist, the basis used for calibration or verification is recorded in accordance with the procedure 4.2.4 – Control of records.
- Each item of measurement or monitoring equipment has its own calibration record, to record calibration schedules, tolerances and records of calibration results.
- All newly purchased measuring and monitoring equipment is checked and registered before use.
- All monitoring and measurement equipment is stored in a manner which prevents damage, abuse or misuse.
- Where appropriate, measurement and monitoring equipment shall be protected from unauthorised adjustment by means of locks, tamper evident labels etc.
- Whenever measuring or monitoring equipment is found to be overdue for calibration or out of calibration, it is withdrawn from service and tagged until its status is determined.
- Product which has been inspected using equipment which is later found to have been out of calibration or overdue for calibration, is identified and immediately quarantined until it has been re-checked using calibrated equipment.
- Company plant and equipment must be maintained in a safe and reliable condition. All plant and equipment details are written up on the Plant and Equipment Register. Records of service and repair work or written up on the Plant and Equipment Maintenance Record Sheet.
- When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed as necessary.
8.1.0 Measurement, analysis and improvement – General
To demonstrate that [enter-your-company-name-here] has planned, documented and implemented procedures for the monitoring, measurement, analysis and improvement processes required to;
- demonstrate conformity to product requirements,
- ensure conformity of the quality management system and
- to continually improve the effectiveness of the quality management system.
The following documentation covers the monitoring, measurement, analysis and improvement of our processes that control product conformity to product requirements and ensure conformity of the quality management system.
- 8.2.1 Customer Satisfaction
- 8.2.2 Internal Audit
- 8.2.3 Monitoring and measurement of processes
- 8.2.4 Monitoring and measurement of product
- 8.3 Control of nonconforming product
- 8.4 Analysis of data
- 8.5.1 Continual Improvement
- 8.5.2 Corrective action
- 8.5.3 Preventative action
8.2.1 Customer Satisfaction
The level of customer satisfaction is one of the indicators of the effectiveness of the Quality Management System. This procedure describes the methods used to capture the information and analyse it.
(This document states the generic details of how a business may respond to this requirement. Your specific response must be completed below in the body of this procedure. Your use of TKO software may impact upon the nature of the response)
[enter-your-company-name-here] has identified customer satisfaction as being a key indicator of the effectiveness of the Quality Management System.
Customer satisfaction data is sourced in various ways, including;
- customer satisfaction surveys,
- customer data on delivered product quality,
- user opinion surveys,
- lost business analysis,
- warranty claims and
- dealer reports.
[enter-your-company-name-here] clearly identifies customer requirements at the quoting or tendering stage.
When appropriate, customers have the opportunity and are encouraged to monitor the production of the product at specific points in the process. (delete this paragraph if it doesn’t apply)
At three monthly intervals, the Sales Manager prepares a list of customers to whom feedback requests will be sent. One week later Sales staff make telephone contact with those customers and actively solicit responses to the feedback request.
The results of this feedback survey are then discussed at the next sales meeting and reported at the next management meeting. Responses requiring corrective action to be taken will become the subject of CAR Forms and will be processed accordingly.
8.2.2 Internal Audit
To define the procedure for planned, regular internal audits which determine whether the Quality Management System is effective and conforms with all requirements.
- [enter-your-company-name-here] has developed a 12 month schedule of internal audits with procedures and activities that are complex or critical being scheduled at six monthly intervals.
- The internal audit plan and procedure conforms to the requirements of the international standard ISO9001-2008 and the Quality Management System that has been established by the organisation.
- A staff member (who) with suitable training, experience and qualifications relevant to the areas being audited, acts as an internal auditor.
- The auditor (s) are selected on the basis that they will be both objective and impartial with respect to the audit process and that they have knowledge of the area that is being audited. An auditor shall not audit their own work or area of responsibility.
- An Internal Audit Report form is used to record and document the audit areas. The form contains guidance for preparation, recorded findings, recommendations and follow-up and closure of recommended actions.
- The audit reports and resulting actions shall be documented stored in accordance with the procedure 4.2.4 – Control of records
- Where corrections and corrective actions are deemed necessary as the result of the audit, the management responsible for the area being audited shall ensure that these are effected without delay.
- Following the corrective action, a formal verification process shall be carried out and documented in accordance with the Corrective Action procedure (8.5.2).
8.2.3 Monitoring and measurement of processes
This procedure describes the methods used for monitoring and measurement as part of the product realisation process.
- (Where necessary, add specific details of how the organisation will respond to this requirement)
- All persons who carry out monitoring and measurement tasks shall be suitably qualified and competent in accordance with the procedure (6.2.2) – Competence, awareness and training.
- A person shall be nominated and authorised to confirm that a product or service is able to be delivered and meets all requirements.
- In some instances, verification may be considered as a monitoring and measurement process. This may be the case where visual checks are used because other measurements are not possible.
- As part of the competency training, individuals are qualified to check their own work.
- In some instances, each successive step in the realisation of the product is checked by the person who carries out the work before passing it on.
- A suitable method of recording that the checks have been carried out shall be included in the work records, such as an initialled box against a description of the check required.
- If required, the verification of the checking process may take the form of checklists with records of items such as dimensions, temperature, physical properties, chemical analysis etc.
- Final inspection includes a check that all inter-process checks have been completed and are satisfactory. This includes a check of all paperwork and documentation that may accompany the product.
The monitoring and measurement that is to be carried out may be listed in a number of ways, such as:
- a quality plan,
- a sampling plan,
- an inspection and test plan,
- a procedure,
- an instruction, and
- the customer’s order
Where the product or service is dispatched before test results, etc. are available, a tracking system shall be implemented to allow for the re-call of the product in the event of a problem being detected at a later date.
All inspection and test records shall indicate whether any failures occurred and the proposed action as a result of the failures. Processing actions that are necessary to bring the product or service within specifications before it is released to the next stage of operations are not considered failures.
Any failures are dealt with in accordance with the procedure for control of non conforming product (8.3)
All relevant documents are retained and stored in accordance with the procedure 4.2.4 – Control of records
8.2.4 Monitoring and measurement of product
To establish appropriate testing and inspection regimes for monitoring conformity of supplied product or services.
(Depending upon the complexity of the product, there may be rigorous inspection and testing procedures to ensure conformity of product or service. Alternatively it may only be necessary to conduct a visual inspection prior to supply. Select whichever of the following paragraphs suits the application.)
For simple supply
Before the product is released to the customer, a suitably qualified person shall review and confirm the order against the supply. A brief visual review is conducted to ensure that there are no obvious defects or nonconformities such as damaged product, packaging or incorrect labelling. Persistent or significant nonconformity will be identified and may form the basis of a CAR procedure.
For all other instances
This procedure relates to inspection and test points, monitoring and measurement of product realisation processes. Before commencement of the job, inspection and test points are agreed with the customer.
The job plan including recommended inspection and test points is explained to and reviewed with the customer.
Any major nonconformance detected at any of the inspection and test points will be recorded on a CAR form and appropriate action taken in consultation with the customer.
Specialised tests may be conducted by suppliers, sub-contractors or consultants and may include:
- U.V. Stability (for example)
- Concrete testing (for example)
- Compliance testing (for example)
Any final measurements or quantities are compared with the original or agreed specification and contracts and any adjustments to the final sign-off are made and agreed with all relevant stakeholder’s.
If a client’s representative supervises the final inspection and tests; when he/she is satisfied, may issue a Letter of Completion and Approval or other appropriate documentation.
Unless otherwise approved by a relevant authority and, where applicable, by the customer, release of product and delivery of service to the customer shall not proceed until the planned arrangements (7.1) have been satisfactorily completed.
All records that authorise the release of the product or service shall clearly identify the person authorising the release.
All monitoring and measurement records, together with other relevant documentation is stored in accordance with the procedure 4.2.4 – Control of records
8.3.0 Control of nonconforming product
To ensure that nonconforming product is identified and controlled.
[enter-your-company-name-here] shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.
In dealing with nonconformities, the organisation will, depending upon the circumstances, act in one or more of the following ways;
- take appropriate action to eliminate the detected nonconformity;
- authorise the release or acceptance under concession by a relevant authority and, where applicable, by the customer;
- take action to preclude its original intended use or application;
- take action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
(This is a generic document that describes how a business may respond to this requirement. A documented procedure should be established to define the controls and related responsibilities and authorities for dealing with nonconforming product. A specific response must be completed below in the body of this procedure.)
The procedure for witness and hold points is as follows:
- The engineer and/or site supervisor advises personnel and sub-contractors of any pending witness or hold point, or an inspection is either specified by the client or a stipulated in an approved technical procedure.
- Where any process or installed material cannot be inspected usually or by other means the engineer and/or site supervisor ensures that the personnel responsible for the task are suitably qualified and experienced, and that the process is continually monitored.
- The status of in-process testing is recorded on the job sheet.
- Where any notation indicates that there are nonconformities on any section of work or with any procedure, no further activity involving that work can proceed.
- All personnel, sub-contractors and client representatives are advised of this requirement.
- Nonconformities are marked and actioned accordingly.
Authorised personnel, upon final inspection, verify that all required inspections have taken place, are recorded, and ensure that any nonconformities or defects have been documented, rectified, reinspected, re-tested and has passed inspection.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained and stored in accordance with the procedure 4.2.4 – Control of records
8.4.0 Analysis of data
To demonstrate the manner in which [enter-your-company-name-here] sources data and then uses it to determine the effectiveness of the Quality Management System and to identify opportunities for improvement.
Analysis of the data provides information relating to;
- customer satisfaction,
- conformity to product requirements,
- characteristics and trends of processes and products, including opportunities for preventive action.
- [enter-your-company-name-here] gathers data from various sources, including customer surveys, Corrective Action Required reports, inspection and test reports, supplier performance reports, sales and marketing reports etc.
- The data is correlated and the results used to identify trends. The trend data may indicate problems associated with processes, training, documentation, product specifications, suppliers, raw materials and many more.
- The results from the evaluation of the data and trends are used as a basis for changes and improvements to the Quality Management System.
The results from the evaluation of the data may also be used :
- as input to management reviews
- as input to decision processes for corrective and preventative actions
- as inputs to assessing customer satisfaction
- as evidence of conformance to customer requirements
8.5.1 Continual Improvement
[enter-your-company-name-here] is committed to the continual improvement of its Quality Management System; this procedure indicates the various methods employed to achieve this.
- [enter-your-company-name-here] has developed a Quality Management System (QMS) and has a stated commitment towards improving the effectiveness of the system.
- Top management has endorsed the organisation’s Quality Policy which, together with its stated quality objectives, contains support for the continual improvement of the QMS.
- [enter-your-company-name-here] conducts regular, planned internal audits of the QMS. The results of these audits are reviewed at regular management meetings and the outcomes are used to assess the performance of the system.
- Whenever nonconformities or system failures are detected, changes to the QMS may be made as the result of corrective action to prevent a recurrence. Preventive action measures may result in changes to the QMS where these are deemed appropriate by top management.
- Data from customer surveys, Corrective Action Required logs and other external and internal sources is used to assess the effectiveness of the QMS. Whenever trends are detected, these are investigated to determine whether there is a need for change to the QMS. Following a change to the QMS and when appropriate, further data is obtained to verify the validity of the change.
- [enter-your-company-name-here]’s top management has a stated commitment to regular management review of the QMS and its outcomes.
8.5.2 Corrective action
To document the corrective actions necessary to eliminate the causes of nonconformities, including complaints, in order to prevent their recurrence and drive continual improvement of the Quality Management System.
Corrective actions are implemented as appropriate, considering the effects of the nonconformities.
[enter-your-company-name-here] has established procedures that record and review all reported nonconformities, including instances of customer complaint and detail the necessary corrective action.
Corrective Action Required
- When a non-conformance is identified a Corrective_Action_Required (CAR) form will be completed. All staff are trained and encouraged in the use of CAR forms.
- After completing the details, the CAR form is passed to the Quality Manager. If appropriate, the CAR is discussed at staff meetings.
- The Quality Manager then processes the form promptly, identifying underlying or root causes and notes these on the form.
- The Quality Manager will then proceed with appropriate corrective or preventive action, noting these on the form.
- A Corrective_Action_Required_Log will be maintained by the Quality Manager, and the status of the CAR will be maintained. CAR issues that are outstanding will be followed up regularly.
- The CAR log will be presented at the regular quality management meetings. The Quality Manager has the responsibility for making the appropriate changes to procedures, forms and management systems as required, from issues arising from the CAR forms.
- Top management will review and approve major CAR actions.
All instances of nonconformance are evaluated to determine the cause and the effect that they have on product realisation, safety, customer satisfaction etc.
As part of the evaluation process, any action to prevent a recurrence of the non-conformance is considered and evaluated. During this evaluation consideration is given to the potential for a recurrence, safety, customer satisfaction, legal and regulatory implications etc.
Following the evaluation of the cause, potential for recurrence and the effects upon product realisation, consideration is given to determine the most appropriate method reducing or eliminating the risk of recurrence.
Communication and Documentation
All evaluation results and corrective actions taken to mitigate or eliminate the potential for further non-conformances are communicated to all relevant parties, recorded and stored in accordance with the procedure 4.2.4 – Control of records
The effectiveness of corrective actions are reviewed on a regular basis, every three (3) months or as deemed necessary by top management. Where the non-conformance is considered to be serious, the frequency of review may be increased as deemed necessary by top management in order to ensure effective control. When a non-conformance is detected, additional work instructions, training and checklists may developed to prevent the recurrence.
Major corrective action is necessary when the non-conformance includes complaints which have legal or financial impact or which might impact upon the reputation of the organisation.
Minor corrective action is necessary when the non-conformance includes complaints which are minimal or low impact and are easily resolved, with no long-term effects.
8.5.3 Preventative action
To document the actions necessary to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are implemented as appropriate, considering the effects
of the potential problems.
- [enter-your-company-name-here] has established procedures that identify the causes of potential nonconformities and methods by which these may be prevented.
- During the planning stage of product realisation, a thorough study of potential non-conformances is conducted. The study will include an examination of the root causes, evaluation of the possibility that the non-conformance will occur and the collateral effect on other processes.
- From the results of the study of potential non-conformances, an evaluation of the need for preventative action will be made. Following this evaluation, any actions that are determined necessary will be implemented.
- All evaluation results and actions taken to eliminate or mitigate the non-conformances are communicated to all relevant parties, recorded and stored in accordance with the procedure 4.2.4 – Control of records
- The effectiveness of preventative actions are reviewed on a regular basis, every three (3) months or as deemed necessary by top management. During the first days, months, of product realisation the frequency of review shall be increased as deemed necessary by top management in order to ensure effective control.
- When a potential non-conformance is detected, additional work instructions, training and checklists are developed to prevent the occurrence.
- [enter-your-company-name-here] regularly conducts customer surveys to gain feedback that assist with the development of preventative action plans.
- [enter-your-company-name-here] encourages its staff to keep up-to-date with industry changes, changes to regulations and codes of practice, new procedures, new materials and products etc. which will have a positive effect on its ability to detect potential non-conformances and prevent these from occurring.
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